The medical device industry is highly regulated and requires quality systems to be assessed for products to be manufactured. From stents to regenerative medicines, the medical device manufacturing sector is highly diversified and is known for producing high-quality products using advanced technology.

Products & Services

    We provide a range of safety evaluation and biocompatibility services for medical devices, including studies designed in accordance with ISO 10993 and USP guidelines.

    • Skin irritation studies
    • Sensitization studies
    • Hemolysis studies
    • Cytotoxicity testing
    • Genetic toxicology
    • Acute, subchronic and chronic toxicology
    • Implantation studies
    • Biodegradation studies
    • Reproductive and carcinogenicity studies
    • Disinfectant efficacy and validation
    • Bioburden
    • Sterility
    • Pyrogenicity
    • Viral clearance studies

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Products & Services

    Charles River offers a line of single-step rapid testing systems which include assays for quick and quantitative endotoxin analysis, glucan contamination testing and gram identification. Our rapid test methods allow you to produce results right at the point of sample collection, improving sample management, decreasing testing time and accelerating product production.

    Endosafe®-PTS™
    Endosafe® nexgen-PTS™
    Endosafe®-MCS™
    Endosafe® Nexus™

Products & Services

    Charles River supports developers and manufacturers of medical devices from the proof-of-concept stage to pivotal safety and efficacy evaluations.

    We are able to offer an integrated approach to medical device studies with a commitment to scientific excellence, an appreciation for client-specific issues and an understanding of regulatory considerations.

    • Protocol preparation
    Necropsy support
    • Sample preparation
    • Histopathology
    Electron microscopy
    • Photographic documentation
    • Morphometric evaluation
    • Plastic embedding and sectioning of all materials (e.g., intact stents, bone devices)
    • Imaging

Products & Services

    Our scientists, located in both the United States and Europe, have more than 20 years of experience in supporting clients throughout the design and performance of viral clearance studies.

    Study Design
    • Selection of process steps
    • Verification of scaled-down process steps
    • Selection of viruses (TSE spike)
    • Performance of study
    • Interpretation and troubleshooting of results

    Product Experience
    • Monoclonal antibodies
    • Recombinant proteins
    • Transgenic products
    • Tissue-derived products
    • Blood-derived products
    • Medical devices

Products & Services

    Monitor your facility and products against bacterial contamination.

    Data gathered from a well-designed and executed environmental monitoring (EM) program provide critical information for tracking and trending on a routine basis. Accurate and consistent species-level identifications result in more confidence in the control of your environment.

    AccuGENX-ID®
    AccuPRO-ID®